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performance of third-party replacement
parts for use with our medical device.
Lors de la maintenance de l'appareil,
utilisez toujours des pièces de rechange
conformes aux normes Advantech.
Advantech Medical ne peut pas garantir
ou endosser les performances
sécuritaires des pièces de rechange
tierces à utiliser avec notre dispositif
médical.
16. Make sure the user does not allow contact between
SIP/SOPs and the patient at the same time.
17. When networking with electrical devices, the
operator is responsible for ensuring that the resulting
system meets the requirements set forth by the
following standards:
– EN 60601-1 (IEC 60601-1)
Medical electrical equipment
Part 1: General requirements for safety
– EN 60601-1-1 (IEC 60601-1-1)
Medical electrical equipment
Part 1-1: General requirements for safety
Collateral standard: Safety requirements for
Medical electrical systems
– EN 60601-1-2 (IEC 60601-1-2)
Medical electrical equipment
Part 1-2: General requirements for safety
Collateral standard: Electromagnetic compatibility;
Requirements and tests
18. Follow national, state or local requirements to
dispose of unit.
19. Maintenance: to properly maintain and clean the
surfaces, use only the approved products or clean
with a dry applicator.
20. Contact information:
No.1, Alley 20, Lane 26, Rueiguang Road
Neihu District, Taipei, Taiwan 114,
R.O.C.
TEL: [phone]
21.
22. This equipment shall not be used as a life support
system.
23. Accessory equipment connected to analog and
digital interfaces must be in compliance with the
respective nationally harmonized IEC standards
(i.e. IEC 60950 for data processing equipment,
IEC 60065 for video equipment, IEC 61010-1 for
laboratory equipment, and IEC 60601-1 for
medical equipment.) Furthermore all
configurations shall comply with the system
standard IEC 60601-1- 1. Anyone who connects
additional equipment to the signal input part or
signal output part is configuring a medical system,
and is therefore, responsible that the system
complies with the requirements of the system
standard IEC 60601-1-1. The unit is for exclusive
interconnection with IEC 60601-1 certified
equipment in the patient environment and IEC
60XXX certified equipment out-side of the patient
environment. If in doubt, consult the technical
services department or your local representative.
24. Grounding reliability can only be achieved when
the equipment is connected to an equivalent
receptacle marked "Hospital Only" or "Hospital
Grade".
25. Use a power cord that matches the voltage of the
power outlet, which has been approved and
complies with the safety standard of your
particular country.
26. Do not place the power cord where it is difficult to
disconnect and may be stepped by other person
Environmental protection.
Follow national requirements to
dispose of unit.
27. “WARNING - Do not modify this equipment
without authorization of the manufacturer.”
28. “WARNING – To avoid risk of electric shock, this
equipment must only be connected to a supply
mains with protective earth.
29. “CAUTION: This adapter FSP / FSP065-DBCM1
is a forming part of the medical device.”
30. Remove the power cord to fully turn off the device
when the battery pack is empty.
31. Classification:
1). Class II
2). No applied part
3). Continuous Operation
32. CAUTION! This product: AIM-78H is used with the
Qualified & certificated power adapter: FSP /
FSP065-DBCM1. Output: Output: 19Vdc, 3.43A
max
33. DISCLAIMER: This set of instructions is given
according to IEC 704-1. Advantech disclaims all
responsibility for the accuracy of any statements
contained herein.
34. In case of serious incident that has occurred,
please contact the manufacturer and local
authorities immediately.
Notice: It is recommended to install the
appropriate soft if have any question, please
contact the manufacturer for further assistance.
Notice: To prevent unauthorized access, it is
recommended to install suitable anti-virus
software or do not connect to unsafe external
networks
Complies with FDA performance standards for laser
products except for deviations pursuant to Laser
Notice No. 50, dated (Insert date of this guidance.)
IEC 60825:2007
Caution - Use of controls or adjustments or performance
of procedures other than those specified herein may
Attention!